TY - JOUR
T1 - The haemostatic effect of deep-frozen platelets versus room temperature-stored platelets in the treatment of surgical bleeding
T2 - MAFOD—study protocol for a randomized controlled non-inferiority trial
AU - Rijnhout, Tim W.H.
AU - Noorman, Femke
AU - van der Horst, Robert A.
AU - Tan, Edward C.T.H.
AU - Viersen, Victor V.A.
AU - van Waes, Oscar J.F.
AU - van de Watering, Leo M.G.
AU - van der Burg, B. L.S.Borger
AU - Zwaginga, Jaap J.
AU - Verhofstad, Michael H.J.
AU - Hoencamp, Rigo
N1 - Funding Information:
The MAFOD study is funded by the Dutch Ministry of Defence and the Dutch Army Health Insurance Foundation (SZVK). The funder had no role in the study design, data collection and analysis.
Publisher Copyright: © 2022, The Author(s).
PY - 2022/9/24
Y1 - 2022/9/24
N2 - Background: The Netherlands Armed Forces have been successfully using deep-frozen (− 80 °C) thrombocyte concentrate (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for the effectiveness and safety of DTCs is currently lacking. Therefore, the MAssive transfusion of Frozen bloOD (MAFOD) trial is designed to compare the haemostatic effect of DTCs versus room temperature-stored platelets (RSP) in the treatment of surgical bleeding. Methods: The MAFOD trial is a single-blinded, randomized controlled non-inferiority trial and will be conducted in three level 1 trauma centres in The Netherlands. Patients 12 years or older, alive at hospital presentation, requiring a massive transfusion including platelets and with signed (deferred) consent will be included. The primary outcome is the percentage of patients that have achieved haemostasis within 6 h and show signs of life. Haemostasis is defined as the time in minutes from arrival to the time of the last blood component transfusion (plasma/platelets or red blood cells), followed by a 2-h transfusion-free period. This is the first randomized controlled study investigating DTCs in trauma and vascular surgical bleeding. Discussion: The hypothesis is that the percentage of patients that will achieve haemostasis in the DTC group is at least equal to the RSP group (85%). With a power of 80%, a significance level of 5% and a non-inferiority limit of 15%, a total of 71 patients in each arm are required, thus resulting in a total of 158 patients, including a 10% refusal rate. The data collected during the study could help improve the use of platelets during resuscitation management. If proven non-inferior in civilian settings, frozen platelets may be used in the future to optimize logistics and improve platelet availability in rural or remote areas for the treatment of (massive) bleeding trauma patients in civilian settings. Trial registration: ClinicalTrials.gov NCT05502809. Registered on 16 August 2022.
AB - Background: The Netherlands Armed Forces have been successfully using deep-frozen (− 80 °C) thrombocyte concentrate (DTC) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. However, high-quality evidence for the effectiveness and safety of DTCs is currently lacking. Therefore, the MAssive transfusion of Frozen bloOD (MAFOD) trial is designed to compare the haemostatic effect of DTCs versus room temperature-stored platelets (RSP) in the treatment of surgical bleeding. Methods: The MAFOD trial is a single-blinded, randomized controlled non-inferiority trial and will be conducted in three level 1 trauma centres in The Netherlands. Patients 12 years or older, alive at hospital presentation, requiring a massive transfusion including platelets and with signed (deferred) consent will be included. The primary outcome is the percentage of patients that have achieved haemostasis within 6 h and show signs of life. Haemostasis is defined as the time in minutes from arrival to the time of the last blood component transfusion (plasma/platelets or red blood cells), followed by a 2-h transfusion-free period. This is the first randomized controlled study investigating DTCs in trauma and vascular surgical bleeding. Discussion: The hypothesis is that the percentage of patients that will achieve haemostasis in the DTC group is at least equal to the RSP group (85%). With a power of 80%, a significance level of 5% and a non-inferiority limit of 15%, a total of 71 patients in each arm are required, thus resulting in a total of 158 patients, including a 10% refusal rate. The data collected during the study could help improve the use of platelets during resuscitation management. If proven non-inferior in civilian settings, frozen platelets may be used in the future to optimize logistics and improve platelet availability in rural or remote areas for the treatment of (massive) bleeding trauma patients in civilian settings. Trial registration: ClinicalTrials.gov NCT05502809. Registered on 16 August 2022.
UR - https://www.scopus.com/pages/publications/85138458997
U2 - 10.1186/s13063-022-06739-2
DO - 10.1186/s13063-022-06739-2
M3 - Article
C2 - 36153539
AN - SCOPUS:85138458997
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 803
ER -